Study On The Effect Of GW876008 On Cerebral Blood Flow In Irritable Bowel Syndrome (IBS) Patients And Healthy Volunteers
| Status: | Completed |
|---|---|
| Conditions: | Irritable Bowel Syndrome (IBS) |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 5/17/2017 |
| Start Date: | November 2006 |
| End Date: | October 2008 |
A Phase IIa Experimental Medicine Study Assessing Alterations in Regional Cerebral Blood Flow by Functional Magnetic Resonance Imaging (fMRI) in Female IBS Patients and Healthy Controls Following Single Doses of GW876008, a Corticotrophin Releasing Factor 1 Receptor Antagonist (CRF1-RA)
This is a three-period crossover study to compare GW876008 and placebo to see if GW876008
will normalise blood flow responses after different emotional stimuli.
will normalise blood flow responses after different emotional stimuli.
Inclusion Criteria:
- The subject should not have been taking and medication for the treatment of IBS for 1
month prior to the study
- Negative serum pregnancy tests (serum a-HCG negative) at Screening (Visit 1), and
negative urine pregnancy tests at Visits 1, 2, 3 prior to study medication dose.
- Non-tobacco user (abstinence from tobacco use for at least 1 month before the start
of the study).
- Normal electrocardiogram (subjects must have no clinically significant abnormalities
on a 12-lead ECG at screen).
Exclusion Criteria:
- Subjects who are pregnant or nursing.
- Current evidence, or history of (at any time in the past) of a biochemical or
structural abnormality of the digestive tract. including (but not limited to):
inflammatory bowel disease (Crohn's disease or ulcerative colitis); functional
dyspepsia; lactose intolerance, not on a stable diet; Celiac Disease
- Subjects who are taking NSAIDs on a regular basis or within 48 hours of a study day.
- The subject has a positive pre-study urine drug/alcohol screen.
- A positive pre-study HIV 1 / 2, Hepatitis B surface antigen or positive Hepatitis C
antibody result within 3 months of the start of the study.
We found this trial at
1
site
Click here to add this to my saved trials
